Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
This is a prospective study of pediatric patients with congenital heart disease, in which acetaminophen serum concentrations will be measured following a single intraoperative intravenous dose of acetaminophen. These levels will be used to develop a pharmacokinetic model. Serum concentrations will be compared between two groups of patients: (1) cyanotic patients presenting for the Fontan completion operation and (2) patients with acyanotic congenital heart disease presenting for repair via median sternotomy.
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Cyanotic CHD | Cyanotic congenital heart disease (CHD) patients presenting for Fontan palliation. |
| |
| Acyanotic CHD | Acyanotic congenital heart disease (CHD) patients presenting for repair via median sternotomy. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Acetaminophen | Drug | IV acetaminophen given as part of standard of care. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Acetaminophen Serum Concentrations | The amount of acetaminophen in the blood stream at each time point after receiving a standard dose. | 15-20 minutes; 30-40 minutes; 50-70 minutes; 80-100 minutes; 2 Hours, 4 Hours; and 6-Hours Post-IV acetaminophen administration |
Not provided
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Pediatric congenital heard disease patients undergoing cardiac surgery and receiving IV acetaminophen during their surgical procedure as standard of care.
Not provided
Not provided
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Nationwide Children's Hospital | Columbus | Ohio | 43205 | United States |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| FG000 | Cyanotic CHD | Cyanotic congenital heart disease (CHD) patients presenting for Fontan palliation. Acetaminophen: IV acetaminophen given as part of standard of care. |
| FG001 | Acyanotic CHD | Acyanotic congenital heart disease (CHD) patients presenting for repair via median sternotomy. Acetaminophen: IV acetaminophen given as part of standard of care. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | Cyanotic CHD | Cyanotic congenital heart disease (CHD) patients presenting for Fontan palliation. Acetaminophen: IV acetaminophen given as part of standard of care. |
| BG001 | Acyanotic CHD |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Acetaminophen Serum Concentrations | The amount of acetaminophen in the blood stream at each time point after receiving a standard dose. | Posted | Median | Inter-Quartile Range | mcg/mL | 15-20 minutes; 30-40 minutes; 50-70 minutes; 80-100 minutes; 2 Hours, 4 Hours; and 6-Hours Post-IV acetaminophen administration |
|
1 week
Not provided
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Cyanotic CHD | Cyanotic congenital heart disease (CHD) patients presenting for Fontan palliation. Acetaminophen: IV acetaminophen given as part of standard of care. |
Not provided
Not provided
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Peter Winch | Nationwide Children's Hospital | 614-722-5936 | peter.winch@nationwidechildrens.org |
Not provided
| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Nov 30, 2021 | Feb 28, 2023 | Prot_SAP_000.pdf |
Not provided
| ID | Term |
|---|---|
| D006330 | Heart Defects, Congenital |
| ID | Term |
|---|---|
| D018376 | Cardiovascular Abnormalities |
| D002318 | Cardiovascular Diseases |
| D006331 | Heart Diseases |
| D000013 | Congenital Abnormalities |
Not provided
Not provided
| ID | Term |
|---|---|
| D000082 | Acetaminophen |
| ID | Term |
|---|---|
| D000083 | Acetanilides |
| D000813 | Anilides |
| D000577 | Amides |
| D009930 | Organic Chemicals |
| D000814 |
Not provided
Not provided
Not provided
Not provided
Not provided
Acyanotic congenital heart disease (CHD) patients presenting for repair via median sternotomy.
Acetaminophen: IV acetaminophen given as part of standard of care.
| BG002 | Total | Total of all reporting groups |
| Participants |
|
| Age, Continuous | Median | Inter-Quartile Range | years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| Cardiopulmonary bypass time | The length of time the subjects were on cardiopulmonary bypass during the surgery. | Median | Inter-Quartile Range | minutes |
|
|
|
| 0 |
| 15 |
| 0 |
| 15 |
| 0 |
| 15 |
| EG001 | Acyanotic CHD | Acyanotic congenital heart disease (CHD) patients presenting for repair via median sternotomy. Acetaminophen: IV acetaminophen given as part of standard of care. | 0 | 15 | 0 | 15 | 0 | 15 |
Not provided
Not provided
Not provided
| D009358 | Congenital, Hereditary, and Neonatal Diseases and Abnormalities |
| Aniline Compounds |
| D000588 | Amines |